Comparison of Warfarin Dosing Using Decision Model Versus Pharmacogenetic Algorithm

Atrial Fibrillation Clinical Trial

Official title:

Warfarin Dosing: Pharmacogenetic Algorithm Compared to Pharmacist's Dosing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00511173
• Other study ID #: 06-14171
• Status: Completed
• Phase: Phase 4
• First received: August 1, 2007
• Last updated: December 7, 2012
• Start date: August 2006
• Est. completion date: November 2008

Study information

• Verified date: December 2012
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a prospective comparison of clinician dosing and a pharmacogenetic algorithm in diagnosed patients requiring warfarin therapy.

Description:

Diagnosed patients with atrial fibrillation, pulmonary embolism, or deep venous thrombosis requiring warfarin therapy will be consented and a tube of blood for DNA analysis will be drawn. The clinician dosing group will not be eligible to obtain the pharmacogenetic results and the algorithm group will have their warfarin pharmacogenetic SNPs performed and integrated into the algorithm and the warfarin dose will be calculated. Outcomes of patients receiving both methods will be gathered and statistically analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 90 Years

Eligibility

Inclusion Criteria:

• Diagnosed patients with atrial fibrillation, deep venous thrombosis, or pulmonary embolism requiring warfarin therapy

Exclusion Criteria:

• Patients with atrial fibrillation, deep venous thrombosis, or pullmonary embolism requiring warfarin therapy who do not consent to participate

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Atrial Fibrillation
• Deep Vein Thrombosis
• Pulmonary Embolism
• Venous Thrombosis

Intervention

Genetic:
• Warfarin Dose based on pharmacogenetics
Warfarin dose adjustment will be based on the standard clinician dosing compared to the use of the pharmacogenetic base algorithm

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In Patients Receiving Warfarin, a Pharmacogenetic Algorithm Dose Was Compared to Clinician Dosing (mg/wk).	Warfarin pharmacogenetic algorithm dosing (mg/wk) was compared to clinician warfarin dosing (mg/wk).	six months	No